Apparatus for sterile docking of male medical line connectors

ABSTRACT

A docking station for maintaining sterilization of temporarily disconnected male medical line connectors. The docking station has a plurality of docking bays, each of which retains an ampule therein containing sterilization fluid and has an access mouth exteriorly exposed when the ampule is secured in its respective bay. The mouth of the ampule is provided with a female medical line connection for temporarily receiving and securing one of the male line connector temporarily disconnected from a patient. A tubular tip and the concentric connection collar of the one of the male medical line connectors is thereby immersed in the sterilization fluid for sterilization while docked.

CROSS REFERENCE

This application is a division of U.S. application Ser. No. 12/590,369,filed on 6 Nov. 2009, which is a continuation-in-part of U.S.application Ser. No. 12/074,951, filed on 7 Mar. 2008, and entitledAPPARATUS AND METHOD FOR STERILE DOCKING OF MALE MEDICAL LINECONNECTORS.

FIELD OF THE INVENTION

The present invention relates to the field of medical liquidadministration, and more particularly, to a docking apparatus and methodfor simultaneously enhancing the sterility, temporary securement anddisinfection of disconnected medical infusion tubing during periods ofnon-use.

BACKGROUND OF THE INVENTION

Improvements in patient safety have been among the primary concerns ofmany efforts in today's healthcare industry. Healthcare associatedinfections remain a major area of focus for these efforts. The Centerfor Disease Control and Prevention cites healthcare associatedinfections in the top ten leading causes of death in the United States.Annually, healthcare associated infections account for an estimated 1.7million infections in hospitals, 99,000 associated deaths, and 4.5 to5.7 billion dollars in added patient care costs.

The reduction of healthcare associated infections depends upon awarenessand adherence to aseptic technique when handling medical equipment thatcomes into direct contact with a patient. Medical equipment isconstantly threatened by exposure to surrounding contaminated surfaces.These surfaces contain microorganisms (bacteria) which can easily adhereto the surface of medical equipment. Once contaminated, the medicalequipment becomes a danger to the patient and can serve as a silentkiller. Healthcare institutions use millions of intravenous catheterseach year. These catheters are at risk of contamination by a variety ofmechanisms. One such mechanism relates to the contamination of theexposed tip of an intravenous administration set. This particularproblem arises when an intravenous infusion line is temporarilydisconnected from a patient (a process which can occur multiple timesper day for an individual patient). During the time that the infusionline is disconnected from the patient, the exposed tip of theintravenous tubing may contact potential contaminants. Thesecontaminants can then lead to infection within a patient's bloodstreamonce the infusion tubing is reconnected to the patient.

The critical event in the aforementioned circumstance is the failure toretain the sterility of the infusion tubing tip and failure toadequately disinfect the tip in the instance of inadvertentcontamination during the time of disconnect from the patient. This riskis, in part, an unanticipated outcome of the somewhat recentimplementation of needle-less intravenous systems. Prior to theintroduction of these needle-less systems, healthcare practitionerstypically replaced the needle used to connect the infusion tubing to theintravenous tubing with a new sterile, capped needle to preventcontamination when the line was hanging between uses. Currently, manypractitioners are not actively considering the risk of contamination andare not taking steps to secure the sterility of the exposed tubing. Whenefforts are made to maintain the sterility of the exposed tubing tip,these efforts are both cumbersome (and therefore at times skipped over),or they fail due to technical shortcomings.

Safe practice recommendations include the use of aseptic technique whenhandling medical infusion lines. The aseptic technique, as pertainsspecifically to intravenous catheters, includes covering the exposed endof intravenous tubing used for intermittent infusions with a sterile capbetween uses and to disinfect the cap prior to reattachment to apatient. There currently exists a plain sterile cap for intravenousinfusion tubing that is individually packaged. These caps haveshortcomings which limit their routine use. Specifically, these capsmust be opened from their individual wrappers for use. This processitself can place the cap at risk for infection before it is even placedonto the intravenous tubing as it requires significant manipulation bythe practitioner. In addition, the practitioner may not have one of theindividual wrappers immediately available when needed. Furthermore,these caps do not accomplish any active disinfection of the intravenoustubing tip surface.

Disinfecting the surfaces of medical equipment with alcohol is a wellaccepted and established practice. Evidence exists supporting the use ofa one minute alcohol immersion as adequate disinfectant technique.Current practice often utilizes alcohol cloth swabs to accomplish thetask of disinfecting the surface of medial equipment, includingintravenous tubing. This method has faults limiting its use. Theexposure of the intravenous tubing tip to the cloth swab of alcohol doesnot qualify as an immersion technique. Also, the practitioner may bevery likely to contaminate the tubing tip with their skin which issurrounding the cloth swab as it is being held. Lastly, the alcohol preppads containing the cloth swabs may not be immediately available for useat the time of greatest need.

The docking station herein disclosed includes a means to temporarily andsafely secure the free tip of intravenous tubing (or any other medicalinfusion line) while simultaneously disinfecting that same tip. In thisway, the device and associated method described will adequately providea means to maintain the sterility of a reusable intravenousadministration set (or other medical infusion line) that has beendisconnected from a patient until it is ready to be reattached forfuture use. In addition, the docking station of the present inventionfurther provides a means for ensuring that the device utilized totemporarily store and sterilize the medical line connectors cannot bereused.

SUMMARY OF THE INVENTION

The docking station of the present invention for male medical lineconnectors, such as, but not limited to, IV connectors, indwelling nervecatheters and dialysate connectors, is comprised of a base housing thatis securable to a stationary surface and has a plurality of dockingbays. Each of the docking bays are dimensioned and contoured forrespectively receiving and temporarily retaining capsules or ampulescontaining sterilization fluid, such an alcohol liquid or gel. Each ofthe ampules has a chamber therein containing the sterilization fluid andan access mouth which is exteriorly exposed when the ampule is securedin one of the bays. The mouth of the ampule has a female medical lineconnection, such as a luer lock mechanism, dimensioned and contoured fortemporarily receiving and securing a male medical line connector theretowith the tubular tip of the male connector thereby immersed in thesterilization fluid.

When it is time to reconnect the male medical line connector, it ispulled, along with the connected ampule, from the docking station bay bypulling the connected male connector. Thereafter the male connector isdisconnected from the ampule for reconnection to the patient and theused ampule is discarded.

A removable sterilization cover may be provided over each of the ampulemouths or each of the bays of the docking station.

The ampules are received respectively in the bays of the docking stationby push insert and pull removal. The ampules in a preferred embodimentare respectively received each in a socket provided in the respectivebays with a friction fit for retaining the ampules respectively in thebays. This friction fit may also additionally be provided with a snapfit if desired.

The ampules are secured against rotation in the bays whereby the maleconnectors may be rotatably connected to the respective ampules. Toprovide this securement against rotation, the ampules and bays haveinter-engaging parts whereby the ampules are secured against rotation inthe respective bays.

The base housing of the docking station may be slidably received in aholster which in turn is secured to a normally stationary verticalsurface, such as an IV pole.

Normally the base will be provided in rows on the base housing and therows may in addition be designated by color coding to match acorresponding male medical line connector type.

Absorbent material, such as foam, compressible sponge, fiber or fabric,may also be provided in the ampules for absorbing and retaining thesterilization fluid. In addition, the ampule mouths may be sealed with apierceable membrane for piercing by the tubular tip of the maleconnector when it is secured to the female connection of the ampule.

To further ensure that an ampule containing sterilization fluid whichhas already been used once to secure and sterilize a male medical lineconnector, it cannot be used again the second time, the ampules aresecured against rotation in the clockwise direction in their respectivebays to facilitate total connections of a male medical line connector,but are, however, permitted to freely rotate in a counterclockwisedirection in their respective bays to prevent disconnection of a malemedical line connector therefrom while the connected ampule is retainedin its respective of said bays. To accomplish this, the ampules and bayshave inter-engaging parts whereby the ampules are secured againstrotation in the clockwise direction in their respective bays andpermitted to freely rotate in the counterclockwise direction. Theseinter-engaging parts include latterly extending wings provided on theampules and corresponding recesses in the respective bays receiving thewings. The recesses have ramp surfaces for engaging bottom edges thewings whereby the ampules are forced out of their respective bays whenrotated in the counterclockwise direction. This forces the user toremove the respective ampule from its respective bay in the dockingstation so that the ampule does not remain in the docking station. Inthis manner, another operator cannot be confused into thinking that theampule is fresh, sterile and ready to use. It forces the originaloperator to discard the used ampule. In addition, the respective baysare positioned in respective recesses on the docking station and aremovable sterilization seal respectively covers each of the recessesand thereby covers the respective bays with the ampules retainedtherein. Alternatively, the mouths of the ampules themselves may becovered with removable sterilization seals. This maintains the unusedampules in a sterile condition and also indicates to the operator thatthe respective bay is sterile and unused.

An additional feature is provided wherein the access mouth for eachampule that contains sterilization fluid is exteriorly exposed when theampule is retained in its respective bay, and each ampule mouth isprovided with a female line connection that is dimensioned and contouredfor temporally receiving and securing thereto the male medical lineconnector such that the tubular tip is not only engaged with thesterilization fluid, but also the exposed end portions of the recededconnection collar for the male medical line connector also engage thesterilization fluid whereby all connecting exposed surfaces of the malemedical line connector are sterilized when the connector is docked. Thisembodiment further ensures that when the male medical line connector isreconnected to the patient is in a totally sterile condition. Thechamber of each ampule may also include an annular array of inwardlyprotruding scrubbing finger webs for engaging and scrubbing exteriorsurfaces of the male connector.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects and advantages appear hereinafter in the followingdescription and claims. The accompany drawings show, for the purpose ofexemplification, without limiting the scope of the invention or theappended claims, certain practical embodiments of the present inventionwherein:

FIG. 1 is a perspective view of the docking station of the presentinvention showing the base housing with multiple docking baysrespectively retaining ampules containing sterilization fluid;

FIG. 2 is a perspective view of the docking station of the presentinvention as retained in a holster which in turn is secured to avertically extending IV pole;

FIG. 3 is a perspective view illustrating the apparatus shown in FIG. 2as viewed from the opposite side;

FIG. 4 is a perspective view illustrating a portion of the apparatusshown in FIG. 3 just prior to connection of a male medical lineconnector to an ampule retained in the docking station;

FIG. 5 is an illustration of the apparatus shown in FIG. 4 with the malemedical line connectors engaged with an ampule retained in the dockingstation;

FIG. 6 is an enlarged sectional view of the apparatus illustrated inFIG. 5 as seen along section line VI-VI;

FIG. 7 is a perspective view illustrating a portion of a modifiedembodiment of the docking station of the present invention whichincorporates structure that causes forced removal of the sterilizationampules from the docking station after use and further illustratesremovable sterilization seals covering respective bays before use of therespective ampules retained therein;

FIG. 8 is an enlarged plan view of one of the docking bays with asterilization ampule retained therein of the docking station shown inFIG. 7;

FIG. 9 is a perspective cross sectional view of the combination dockingbay and sterilization ampule contained therein as shown in FIG. 8 and asseen along section line IX-IX;

FIG. 10 is a perspective cross sectional view of the combination dockingbay and sterilization ampule contained therein as seen along sectionline X-X of FIG. 8;

FIG. 11 is an isometric view of another embodiment of the sterilizationampule of the present invention;

FIG. 12 is an isometric cross sectional view of the ampule shown in FIG.11 as seen along section line XII-XII of FIG. 11;

FIG. 13 is an isometric cross sectional view of the ampule shown in FIG.12 with compressible sponge shown in bottom portions thereof, togetherwith a male medical line connector shown in mid cross section prior toinsertion into the ampule;

FIG. 14 is an isometric view in mid cross section illustrating thecombination shown in

FIG. 13 with the male medical line connector seated within the ampulefor sterilization; and

FIG. 15 is an isometric view of the embodiment of the docking station ofthe present invention incorporating the combination male medical lineconnector and sterilization ampules shown in FIGS. 13 and 14.

DESCRIPTION OF PREFERRED EMBODIMENTS

Referring to the drawings, the docking station 10 is provided fordocking male medical line connectors 11. The docking station 10 iscomprised of a base housing 12, which in this instance is constructed oftransparent plastic.

Base housing 12 is provided with a plurality of docking bays 13, each ofwhich is dimensioned and contoured for respectively receiving andtemporarily retaining ampules 14 containing sterilization fluid, liquidor gel alcohol. Each of the ampules 14 have a chamber 15 thereincontaining the sterilization fluid. The chambers 15 contain a foamliquid or gel absorbent material 16 for absorbing and retaining thesterilization fluid. Ampules 14 are each provided with a mouth 17 havinga female medical line connector 18 (luer lock) exteriorly exposed whenthe ampules 14 are secured in one of the respective bays 13. The femalemedical line connector 18 is dimensioned and contoured for temporarilyreceiving and securing a male medical line connector 11 thereto with thetubular tip 20 thereof received in the absorbent material 16 therebyimmersing the tip in sterilization fluid.

Dome shaped sterilization covers 21 are removable received over each ofthe bays 13. The covers 21 are also made of transparent plastic and havetabs 22 extending from a circumferential edge. Tabs 22 are provided witha light adhesive whereby each of the covers 21 may be readily removedindividually by gripping the respective tab 22 and peeling it away fromthe upper surface 23 of base housing 12.

Each of the ampules 14 are received respectively in bays 13 by pushinsert and pull removal. Ampules 14 are respectively received in asocket 24 provided in each of the bays 13 for retaining the ampules 14in bays 13 with a friction snap fit.

The ampules 14 are secured against rotation in bays 13 whereby the maleconnectors 11 may be rotatably connected with a conventional rotationalluer lock to the ampules 14 while the ampules 14 remain secured in theirrespective bays 13. This is accomplished by providing the ampules 14 andthe respective bays 13 with inter-engaging parts 25 whereby the ampules14 are secured against rotation in the bays 13.

These inter-engaging parts 25 consist of wings 26 radially extendingfrom the ampules 14, which in turn are received in corresponding grooves27 of each bay 13.

The mouths 17 of each ampule 14 are sealed with a pierceable membrane 28for piercing by the tubular tip 20 of male connector 11 in order to helpmaintain the internal cavity 15 of ampule 14 in a sterile condition andto also help prevent evaporation of the sterilization fluid, such asalcohol. When membrane 28 is pierced it is caused to annularly penetrateinto chamber 15 and thereby secure and maintain absorbent material 16therein.

The docking station 10 is slidably received in a holster 30, which inturn is removably secured to housing 31, which in turn is secured to avertical surface or support in the form of IV pole 32. The holster 30,or an extra one thereof, may instead be secured to another or differentadjacent surface.

With particular reference to FIGS. 2 and 3, the housing 31 is providedwith an internal cavity 33 for slidably receiving therein from the leftside, as is best seen in FIG. 2, cartridge housing 34, which is open tothe front and contains a stack of the docking stations 10. Housing 31 atthe lower front thereof is provided with an opening 35 for therebypermitting access to the stack of docking stations whereby the bottommost docking station 36 in the stack may be removed and placed into theholster 30 when the docking station 10 previously contained therein hasbeen depleted and is need of change.

As is best seen in FIG. 3, housing 31 on the right side is provided withan opening 37 to provide finger hole access in order to push cartridgehousing 34 out to the left from the cavity 33 for removal once all ofthe docking stations 10 therein have been removed.

Housing 31 is secured to vertical IV pole 32 by means of the clamp 40which is engaged and disengaged in a conventional fashion by rotatingknob 41. Clamp 40 is also provided with an extension 42 for attaching orsecuring accessories, such as another holster 30.

Each of the bays 13 are provided in rows as indicated and, if desired,each of the rows of the base housing 12 may be designated by a differentcolor coding in order to match a corresponding color coding on malemedical line connectors 11 of a different type.

Other than the IV pole 32 and parts of the clamp 40, the entire systemmay be manufactured of plastics.

Referring next to FIGS. 7 through 10 another embodiment of the dockingstation of the present invention is illustrated which preventsaccidental reuse of the ampules 14. In this embodiment, the ampules 14are secured against rotation in the clockwise direction in therespective bays 13 to facilitate threadable connection of a male medicalline connector 11. However, the respective ampules 13 are permitted tofreely rotate in the counterclockwise direction in their respective bays13 to prevent disconnection of a male medical line connector 11 from itsrespective connected ampule 14 while retained in its bay 13. This isaccomplished by the inter-engaging parts 25. The inter-engaging parts 25include the laterally extending wings 26 on opposite sides of theampules 14 and these extending wings 26 are respectively received incorresponding recesses 27′ of bays 13. The recesses 27′ have bottom rampsurfaces 50 which ramp upwardly or outwardly on an incline as theyprogress in the counterclockwise direction. These ramp surfaces 50engage the bottom edges 51 of wings 26 whereby when the ampules 14 arerotated in the counterclockwise direction, as by rotating a connectedmale medical line connector 11 for disconnection, the bottom edges 51 ofwings 26 which are engaging ramp surfaces 50 cause the ampule 14 to bepushed upwardly and outwardly out of its respective bay 13 when theampule is rotated counterclockwise. This forces the operator to actuallyremove the connected ampule from the docking station 10 and tothereafter manually disconnect the medical line connector 11 from theexpelled ampule 14 and to thereafter discard the used ampule 14. Thisprevents accidental reuse of a sterilization ampule 14. As the bottomedges 51 of wings 26 ride upwardly and outwardly on ramp surfaces 50when ampule 14 is turned counterclockwise, this forces the ampule 14 todisengage from its snap in connection in bay 13 as indicated at 24,thereby forceably eject ampule 14 from its respective bay 13.

Instead of the sterilization sealing domes 21 as illustrated in FIG. 1,sterilization seals 21′ are provided in this embodiment. Each of thebays 13 with their respective ampules 14 retained therein are positionedin respective recesses 52 as seen in FIGS. 7 and 9. The upper edges 53and recesses 52 are covered with a foil seal 21′ which is adhered toedges 53 to retain the content thereunder in sterilized condition. Seals21′ are easily removed by grasping an exposed edge 54 thereof andpeeling them off the upper edge 53 of recesses 52.

Referring next to FIGS. 11 through 15, another embodiment of the presentinvention is illustrated. In this embodiment the probe tip 20 of malemedical line connector 11 is not only sterilized when docked, but inaddition the receded concentric connection collar 52 also has itsexposed end portions 53 and exterior portions 54 engaged with thesterilization fluid contained within chamber 15 of ampule 14.Accordingly, all of the exposed end surfaces of the tubular tip 20 andthe connection collar 52 are fully treated with sterilization fluid andsterilized during the docking procedure.

The chamber 15 includes an annular array of inwardly protrudingscrubbing finger webs 55 for engaging and scrubbing interior surfaces ofthe tip 20 and the connection collar 52. These scrubbing finger webs 55are constructed of any suitable material, such as an elastomeric plasticor rubber, absorbing sponge or the like to flexibly engage and scrub theexterior surfaces of the collar 52 and the probe tip 20.

A reservoir of the sterilization fluid may also be retained in thebottom portion of the chamber 15 by compressible sponge 56 asillustrated in FIGS. 13 and 14. The sponge 56 accordingly absorbs thesterilization fluid and expels the fluid upon compression caused byinsertion of the medical male line connector 11.

FIG. 15 illustrates the combination shown in FIGS. 11 through 14 showingthe ampules 14 seated in respective bays 13 of base housing 12. Likeembodiments are all designated with the same reference numerals.

In the embodiment of FIG. 15, the removable seals 21″ seal over theupwardly open mouths of the respective ampules 14 instead of coveringthe respective bays 13 as shown in previous embodiments.

1. A docking station for a male medical line connector including anexposed tubular tip and a receded concentric connection collar, saiddocking station comprising: a base housing having a docking baydimensioned and contoured for receiving and temporarily retaining anampule containing sterilization fluid; said ampule having a chambertherein containing the sterilization fluid and an access mouthexteriorly exposed when said ampule is retained in said bay, said mouthhaving a female line connection dimensioned and contoured fortemporarily receiving and securing the male medical line connectorthereto with the tubular tip and exposed end portions of the connectioncollar engaged with said sterilization fluid.
 2. The docking station ofclaim 1, said chamber including an annular array of inwardly protrudingscrubbing finger webs for engaging and scrubbing exterior surfaces ofsaid tip and connection collar.
 3. The docking station of claim 2,including compressible sponge retained in bottom portions of saidchamber for absorbing and expelling said sterilization fluid.
 4. Thedocking station of claim 1, including a removable seal covering saidmouth.